Rail and/or anchor system for transjugular intrahepatic protosystemic shunt procedure

ABSTRACT

A rail and/or anchor system and method for transjugular intrahepatic portosystemic shunt procedures. The system includes a rail and/or anchor line anchorable to surrounding tissue or used as a rail, and configured to guide the displacement of at least one of a needle and an outer sheath. The rail and/or anchor line may include a balloon catheter, and a balloon of the balloon catheter may be configured to selectively anchor the anchor line to surrounding tissue by the balloon being inflated, and unanchor the anchor line to surrounding tissue by the balloon being deflated. The balloon catheter can be stiff so that it can be used as a rail even when not anchored. The balloon catheter may be configured for executing wedge venography, and for measuring pressure at a tip of the balloon catheter while a balloon of the balloon catheter is inflated. The anchor line may include one or more hooks for anchoring the anchor line to surrounding tissue. The one or more hooks may be selectively advanceable and retractable.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of co-pending U.S. ProvisionalPatent Application Ser. No. 62/610,852 filed Dec. 27, 2017, which isincorporated herein in its entirety.

FIELD OF THE INVENTION

The present disclosure is generally directed to medical procedures, andmore importantly to an improved Transjugular Intrahepatic PortosystemicShunt (TIPS) procedure and system.

BACKGROUND OF THE INVENTION

A Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedureincludes connecting the portal vein (PV) to the hepatic vein (HV) in theliver. The purpose of the procedure is to divert blood from entering theliver, and may be executed on patients with cirrhosis and internalbleeding and/or ascites.

The most difficult portion of a TIPS procedure is accessing the portalvein from the hepatic vein. The device that is currently availablerequires significant expertise, and typically requires a 10 Frenchsheath to be placed into the hepatic vein. A significant problem is thatthe 10 French sheath that is placed in to the hepatic vein often fallsout of the hepatic vein and accessing the hepatic vein needs to berepeated. Also, aiming at the portal vein is usually performed blindlyand aiming at and entering the portal vein can be difficult.

Existing TIPS devices are over 25 years old and do not have anyprovision for maintaining access in the hepatic vein or for performingrepeat hepatic portal venography while attempting to create TIPS via thea same 10 French sheath that has been initially inserted into thehepatic vein during the procedure.

Therefore, there exists a need for a system and method to maintainaccess to the hepatic vein and also a system and method for allowingrepeated portal venography.

SUMMARY OF THE INVENTION

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter. Furthermore,the claimed subject matter is not limited to implementations that solveany or all disadvantages noted in any part of this disclosure.

As one example, disclosed is a rail and/or anchor system fortransjugular intrahepatic portosystemic shunt procedures, the systemcomprising:

a rail and/or anchor line or stiff shaft configured for being anchoredto surrounding tissue and/or stiff enough configured to guide thedisplacement of at least one of a needle and an outer sheath.

In another aspect, the rail and/or anchor line is a balloon catheter,and a balloon of the anchor line is configured to selectively anchor theanchor line to surrounding tissue by the balloon being inflated, andunanchor the anchor line to surrounding tissue by the balloon beingdeflated. If a shaft of the catheter is stiff or stiffened by a wire, itcan be used as a rail with the balloon inflated or deflated.

In another aspect, the rail and/or anchor line is a balloon catheterconfigured for executing wedge venography by discharging a gas orcontrast through the balloon catheter while a balloon of the ballooncatheter is inflated.

In another aspect, the rail and/or anchor line is a balloon catheterconfigured for measuring pressure at a tip of the balloon catheter whilethe balloon is inflated.

In another aspect, the rail and/or anchor line includes one or morehooks for anchoring the anchor line to surrounding tissue.

In another aspect, the rail and/or anchor line includes one or morehooks for anchoring the anchor line to surrounding tissue, and the oneor more hooks are selectively advanceable and retractable.

In another aspect, the rail and/or anchor line includes a balloon andone or more hooks to anchor the anchor line to surrounding tissue.

As another example, disclosed is a rail and/or anchor system fortransjugular intrahepatic portosystemic shunt procedures, the systemcomprising:

an inner rail;an outer sheath configured to be advanced and retracted over the innerrail;a needle configured to be advanced between the inner rail and the outersheath; andthe inner rail with or without an anchor, the anchor configured toanchor the inner rail to surrounding tissue.

In another aspect, the inner rail includes a balloon catheter, and theanchor is a balloon of the balloon catheter, and the balloon isconfigured to anchor the inner rail to the surrounding tissue by beinginflated and unanchor the inner rail to the surrounding tissue by beingdeflated.

In another aspect, the inner rail includes a balloon catheter forexecuting wedge venography by discharging a gas or contrast through theballoon catheter while a balloon of the balloon catheter is inflated.

In another aspect, the inner rail includes a balloon catheter formeasuring pressure at a tip of the balloon catheter while the balloon isinflated.

In another aspect, the anchor includes one or more hooks to hook ontosurrounding tissue.

In another aspect, the anchor includes one or more hooks to hook ontosurrounding tissue, the one or more hooks being selectively advanceableand retractable.

In another aspect, the anchor includes a balloon and one or more hooksto anchor the inner rail to surrounding tissue.

As another example, disclosed is a method of performing a transjugularintrahepatic portosystemic shunt procedure, the method comprising:

advancing a rail and/or anchor line into a patient;anchoring the anchor line to surrounding tissue or positioning the railin the hepatic vein; andguiding the displacement of at least one of a needle and an outer sheathvia the rail and/or anchor line.

In another aspect, the anchor line is a balloon catheter, and a balloonof the balloon catheter is configured to selectively anchor the anchorline to surrounding tissue by the balloon being inflated, and unanchorthe anchor line by the balloon being deflated; and

the method further comprises inflating the balloon to anchor the anchorline.

Alternatively the catheter can be used as a rail if the catheter isstiffened either by a wire or by the catheter material.

In another aspect, the anchor line is a balloon catheter configured forexecuting wedge venography by discharging a gas or contrast through theballoon catheter while a balloon of the balloon catheter is inflated;and

wherein the method further comprises executing wedge venography via theballoon catheter.

In another aspect, the anchor line is a balloon catheter configured formeasuring pressure at a tip of the balloon catheter while the balloon isinflated; and the method further comprises measuring pressure at the tipof the balloon catheter while the balloon is inflated.

In another aspect, the anchor line includes one or more hooks foranchoring the anchor line to surrounding tissue; and the method furthercomprises anchoring the anchor line via the one or more hooks.

In another aspect, the anchor line includes a balloon and one or morehooks to anchor the anchor line to surrounding tissue; and

wherein the method further comprises anchoring the anchor line via atleast one of the balloon and the one or more hooks.

These and other objects, features, and advantages of the presentinvention will become more readily apparent from the attached drawingsand the detailed description of the preferred embodiments, which follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The preferred embodiments of the invention will hereinafter be describedin conjunction with the appended drawings provided to illustrate and notto limit the invention, where like designations denote like elements,and in which:

FIG. 1 schematically presents an exemplary method of performing atransjugular intrahepatic portosystemic shunt procedure, in accordancewith aspects of the present disclosure;

FIG. 2 schematically presents an outer sheath, in accordance withaspects of the present disclosure;

FIG. 3 schematically presents an outer sheath receiving an anchor line,rail, and/or stiff shaft catheter, and a needle, in accordance withaspects of the present disclosure;

FIG. 4 schematically presents a balloon having been inflated, inaccordance with aspects of the present disclosure;

FIG. 5 schematically presents an exemplary use of the disclosed system,where a balloon has been inflated and a needle is puncturing nearbytissue, in accordance with aspects of the present disclosure;

FIG. 6 schematically presents the anchor line with no hooks or retractedone or more hooks, and a deflated balloon, in accordance with aspects ofthe present disclosure;

FIG. 7 schematically presents the rail and/or anchor line with extendedtwo hooks, and an inflated balloon, in accordance with aspects of thepresent disclosure;

FIG. 8 schematically presents the anchor line with extended two hooks,and a deflated balloon, in accordance with aspects of the presentdisclosure;

FIG. 9 schematically presents the anchor line with one extended hook,and a deflated balloon, in accordance with aspects of the presentdisclosure; and

FIG. 10 schematically presents an anchor line having a single hook,without a balloon, in accordance with aspects of the present disclosure.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION

The following detailed description is merely exemplary in nature and isnot intended to limit the described embodiments or the application anduses of the described embodiments. As used herein, the word “exemplary”or “illustrative” means “serving as an example, instance, orillustration.” Any implementation described herein as “exemplary” or“illustrative” is not necessarily to be construed as preferred oradvantageous over other implementations. All of the implementationsdescribed below are exemplary implementations provided to enable personsskilled in the art to make or use the embodiments of the disclosure andare not intended to limit the scope of the disclosure, which is definedby the claims. For purposes of description herein, the terms “upper”,“lower”, “left”, “rear”, “right”, “front”, “vertical”, “horizontal”, andderivatives thereof shall relate to the invention as oriented in FIG. 2.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the inventive concepts defined in theappended claims. Hence, specific dimensions and other physicalcharacteristics relating to the embodiments disclosed herein are not tobe considered as limiting, unless the claims expressly state otherwise.

Disclosed herein is a rail and/or anchor system 200 (FIGS. 2-10) andmethod 100 (FIG. 1) for transjugular intrahepatic portosystemic shuntprocedures. As shown in FIG. 3, system 200 may include a rail and/oranchor line 302 configured for being anchored or secured (held in place)by its stiff shaft to surrounding tissue and configured to guide thedisplacement of at least one of a needle 304 and an outer sheath 306(e.g. a needle 304 and/or an outer sheath 306). For example, the anchorline 302 may allow the sheath to pass through itself, or outside itselfin between an outer wall of the anchor line 302 and an outer sheath 306.

In one example, turning to FIG. 4, the anchor line 302 is, or includes,a balloon catheter. A balloon 402 of the balloon catheter may beconfigured to selectively anchor the anchor line 302 to surroundingtissue by the balloon 402 being inflated (FIG. 5). The balloon mayunanchor the anchor line 302 to surrounding tissue by the balloon 402being deflated (FIG. 6). The balloon catheter may be configured forexecuting wedge venography by discharging a gas or contrast through theballoon catheter while a balloon 402 of the balloon catheter is inflated(FIG. 5). The balloon catheter may be configured for measuring pressureat a tip of the balloon catheter while the balloon 402 is inflated ordeflated. The balloon catheter may be configured to function as a railwithout an anchor if it is stiff shafted by means of wall stiffness orstiff wire.

The anchor line 302 may include one or more hooks 702 (FIG. 7) foranchoring the anchor line 302 to surrounding tissue. The one or morehooks 702 may be selectively advanceable and retractable (FIGS. 6 and7). The anchor line 302 may include a balloon 402 and one or more hooks702 together, to anchor the anchor line 302 to surrounding tissue.

As another example, the system 200 includes an inner rail 302 and anouter sheath 306 configured to be advanced and retracted over the innerrail 302. The inner rail may include none or one or more features andelements of the anchor line 302 described above. The outer sheath 306may be a 10 Fr sheath, for example. But any appropriate sheath may beincluded for enabling the features of the present disclosure. The systemmay include a needle 304 configured to be advanced between the innerrail 302 and the outer sheath 306. The inner rail 302 may include ananchor 404. The anchor 404 may be configured to anchor the inner rail302 to surrounding tissue.

The inner rail 302 may include a balloon catheter, and the anchor 404may be a balloon 402 (FIG. 4) of the balloon catheter. The balloon 402may be configured to anchor the inner rail 302 to the surrounding tissueby being inflated. The balloon 402 may be configured to unanchor theinner rail 302 to the surrounding tissue by being deflated.

The inner rail 302 may include a balloon catheter for executing wedgevenography by discharging a gas or contrast through the balloon catheterwhile a balloon 402 of the balloon catheter is inflated. The inner rail302 may include a balloon catheter for measuring pressure at a tip ofthe balloon catheter while the balloon 402 is inflated.

The anchor 404 may include one or more hooks 702 (FIG. 7) to hook ontosurrounding tissue. The one or more hooks 702 may be selectivelyadvanceable and retractable. The anchor 404 may include a balloon 402and one or more hooks 702, together, to anchor the inner rail 302 tosurrounding tissue.

Further disclosed is a method 100 of performing a transjugularintrahepatic portosystemic shunt procedure. The method 100 may generallyinclude advancing a rail and/or anchor line 302 into a patient,anchoring the anchor line 302 to surrounding tissue or using the railpositioned in the hepatic vain, and guiding the displacement of at leastone of a needle 304 and an outer sheath 306 via the anchor line 302.

More particularly, with reference to FIG. 1, the method may include: at102, advancing a sheath into a hepatic vein, at 104 advancing a ballooncatheter through the sheath, at 106 expanding the balloon for pressuremeasurement, at 108 obtaining a portal venogram, at 110 advancing aneedle to a tip of the sheath (either within the balloon catheter orbetween the balloon catheter and the sheath), at 112 retracting thesheath to the IVC, at 114 retracting the needle and/or the sheath whileballoon remains anchored or positioned in hepatic vein to a desiredlevel for attempt at PV entry, at 116 advancing the needle to puncturethe hepatic vein and enter the portal vein, at 118 determining if theportal vein has been entered by the needle, at 118N if the portal veinis not entered by the needle retracting the needle into the sheath andreadvancing the sheath into the hepatic vein over the balloon catheter,rail, and/or anchor, at 118Y ending the method if the portal vein hasbeen entered by the needle, the balloon catheter, anchor, and/or rail isremoved, the TIPS procedure then proceeds as usual. Step 118 and 118Nmay be repeated until the needle has entered the portal vein. After118N, the method goes back to step 110 and is repeated.

In another example, the method includes removing a dilator after thesheath is advanced into the hepatic vein. Next, the balloon catheter maybe advanced to a tip of the sheath. Next, free hepatic vein pressure maybe measured, and next the balloon may be expanded to measure wedgepressure. Next, portal venography may be executed. For example, wedgeportal venography may be performed while the needle is in the liverparenchyma to determine the position of the needle's tip in relation tothe portal vein, Next, the a needle may be advanced to the tip of thesheath. Next, the sheath may be retracted while the balloon catheter andthe needle remain in place. Next the needle may be retracted while theballoon remains anchored (or positioned) in the hepatic vein. When theneedle is advanced to a desired point in the hepatic vein, the needlemay be advanced to puncture the hepatic vein with the aim of enteringthe liver parenchyma and the portal vein. Next, if the portal vein wasentered by the needle, the balloon catheter and/or anchor may be removedand the TIPS procedure may be subsequently completed.

If the portal vein is not entered by the needle, the needle may beretracted into the sheath, and the sheath may be re-advanced into thehepatic vein over the balloon catheter, anchor, and/or rail, and theneedle may be re-advanced to the tip of the sheath. Next, the sheath maybe retracted and the above described wedge portal venography andsubsequent steps may be re-performed or re-attempted until the needleenters the liver parenchyma and portal vein.

In the method 100, the rail and/or anchor line 302 may be a ballooncatheter, and a balloon 402 of the balloon catheter may be configured toselectively anchor the anchor line 302 to surrounding tissue by theballoon 402 being inflated, and unanchor the anchor line 302 by theballoon 402 being deflated. The method 100 may further include inflatingthe balloon 402 to anchor the anchor line 302. Alternatively, the railand/or anchor line 302 can be used as a rail without anchoring if thecatheter is positioned and maintained in the hepatic vein and thecatheter was stiff or stiffened by a stiff wire.

In the method 100, the anchor line 302 may be a balloon catheterconfigured for executing wedge venography by discharging a gas orcontrast through the balloon catheter while a balloon 402 of the ballooncatheter is inflated. The method may further include executing wedgevenography via the balloon catheter.

In the method 100, the anchor line 302 may be a balloon catheterconfigured for measuring pressure at a tip of the balloon catheter whilethe balloon 402 is inflated. The method 100 may further includemeasuring pressure at the tip of the balloon catheter while the balloon402 is inflated.

In the method 100, the anchor line 302 may include one or more hooks 702for anchoring the anchor line 302 to surrounding tissue. The method 100may further include anchoring the anchor line 302 via the one or morehooks 702.

In the method 100, the anchor line 302 may include a balloon 402 and oneor more hooks 702, together, to anchor the anchor line 302 tosurrounding tissue. The method may further include anchoring the anchorline 302 via at least one of the balloon 402 and the one or more hooks702.

In other words, the disclosed TIPS system and method primarily maintainsaccess in the hepatic vein and also limits the need for multiple passesthrough the parenchyma of the liver. For example, a stiff wire (innerrail 302 or anchor line 302) in a sheath (outer sheath 306) may maintainaccess of the hepatic vein while attempts at entering the portal veincan be made anywhere along the hepatic vein (even at the hepatic veinIVC junction without falling out of the hepatic vein). Maintainingaccess of the hepatic vein without the fear of the sheath falling outwould allow the operator to puncture the hepatic vein close to the IVCwhich may be a preferred location for the puncture.

The method 100 may include using an occlusion balloon type catheter(including balloon 402) through the sheath to act as an anchor (e.g.anchor 404) and also allows one to perform repeated balloon occlusionvenography to allow the operator to target a visualized portal vein(i.e. visualized via the venography). A balloon occlusion gives theadvantages of allowing a proximal hepatic vein puncture and an addedadvantage of being able to perform repeated wedge portal venography.

As a non-limiting example, the disclosed system may be provided as akit, including a stiff guidewire, Robust 10 Fr Sheath, a TIPS needle,and an occlusion balloon, or any appropriate element described herein.The stiff guidewire (inner rail 302 or anchor line 302) maintains accessin the hepatic vein. The 10 Fr sheath is advanceable over the guidewireinto the hepatic vein. An occlusion balloon may be inserted through thesheath over the guidewire or directly and the guidewire may be removed.It is to be understood that removing the guidewire may be optional, andthe guidewire may or may not include the herein disclosed hook anchors.The needle may be advanced through the sheath into the hepatic vein. Thesheath may be withdrawn over the guidewire, catheter, and/or rail toexpose the needle. The needle may be retracted to the desired locationin the hepatic vein and exit the hepatic vein and enter the liverparenchyma anywhere along the hepatic vein without fear of losing accessdue to the disclosed innovation of anchoring the inner rail 302 oranchor line 302 or by means of a stiff shaft catheter (no anchors). Theballoon catheter may be used for repeat wedged venography.

When a balloon is inflated and obstructs the flow in the hepatic vein,the pressure reading at the tip of the catheter will read the pressurein the portal vein, where this pressure may be referred to as wedgepressure. Wedge pressure may reflect a true portal pressure that ismeasured directly in the portal vein. One issue in the prior art is thatrepeat portal venography is not possible once entry into the portal veinis attempted. It may be important to know the pressure before an attemptis made to insert the needle into the portal vein. This pressure may beobtained by a pressure reading at a tip of the balloon catheter whilethe balloon is inflated. The wedge pressure may be determined while theballoon is inflated, because the balloon obstructs outflow through thehepatic vein, and the portal venous pressure is transmitted through theliver parenchyma to the tip of the balloon catheter.

Therefore, the balloon catheter may be used for at least two functionsduring the TIPS procedure. One function of the balloon catheter is toexecute repeat portal venograms at any point during the procedure and asecond function is to maintain access of the hepatic vein so that theTIPS sheath used to access the hepatic vein does not fall out of thehepatic vein and the sheath can be pulled back into the IVC or rightatrium and then re-advanced back into the hepatic vein over the ballooncatheter if needed. A stiffened balloon catheter may be used to add bothstiffness to the device during insertion and to effect repeated portalvenograms and to advance the sheath over it as a rail even if the sheathis retracted into the IVC or Right Atrium. In a wedge portal venogram,the balloon may be inflated and contrast or carbon dioxide gas may beinjected to show the portal vein.

The carbon dioxide gas may be any appropriate gas, without departingfrom the scope of this disclosure. The carbon dioxide gas is dischargeddistally with respect to the balloon and its respective catheter (e.g.the gas may be discharged from a tip of the balloon catheter). In someexamples, the carbon dioxide gas may be injected through the outersheath (e.g. 10 fr sheath), external to the balloon catheter. In yetanother example, carbon dioxide gas may be proximally located withrespect to an inflated balloon, without departing from the scope of thepresent disclosure. It is to be understood that the term proximal refersto a general area or direction away from a working tip of the device,and distal refers to a general area of direction toward a working tip ofthe device.

In one example, the required stiffness of the device (e.g. for advancingthe sheath into the hepatic vein) may be provided solely, or majorly, bya selected material of the 10 Fr sheath, or by a selected material ofthe balloon catheter, or by a selected material of guide wire, or acombination thereof. The stiffness of the device is to be adjusted,selected, or configured to prevent herniation during inserting thedevice or advancement of the sheath over the catheter.

This new system simplifies the TIPS procedure. The guidewire orocclusion balloon will maintain hepatic vein access. The needle will beable to be advanced (e.g. bareback) through the 10 Fr sheath. In someexamples, the needle may need to be protected by a 10 Fr dilator toadvance it safely through the 10 Fr sheath. The 10 Fr sheath may need tobe strengthened so as to allow the needle (e.g. needle 304) to beadvanced bareback. A wire and/or balloon will be specific for thisapplication so that the wire/balloon would fit the 10 Fr sheath. Inaddition an appropriate balloon catheter to dilate the liver parenchymaand a covered stent may be required to complete the TIPS procedure.

It is anticipated that various other configurations may anchor thecatheter, sheath, or generally the device, in the hepatic vein tothereby implement a rail for the sheath to move up and down the rail.The balloon catheter can be used as an anchor, a catheter (without aballoon) can be used as an anchor, or just a wire with an anchorelement, such as a hook, can be used as an anchor. In another example, awire that is stiff enough can be used as an anchor. It is to beunderstood that the term “hook” may refer to any appropriate structurethat selectively (or temporarily) attaches to tissue, and it may be aJ-shaped or L-shaped structure having a pointed or sharp distal end.

A balloon catheter may have an inflatable and deflatable balloon. Anchorelements such as hooks or spokes, similar to spokes or ribs of anumbrella, may be selectively deployed from the catheter to anchor intohepatic tissue and can be selectively released from the hepatic tissueto remove the catheter. The anchor may be a balloon, and/or have one ormore hooks. In one example, the balloon may be eliminated from theanchor, such that a wire has an anchor mechanism without a balloon. Thehook anchor may be retractable within its respective catheter.

It is to be understood that reference to a balloon catheter and/or aguide wire may refer to the above referenced anchor line 302 and/orinner rail 302. Therefore, a needle may pass through the ballooncatheter, or through a sheath that holds a wire having one or morehooks. The needle may also pass along an outer portion of the ballooncatheter between the balloon catheter and an outer sheath (e.g. 10 frsheath). In one example, the device includes a balloon catheter and aneedle passing within the balloon catheter, or through a hole in a wallof the balloon catheter.

It is anticipated that, without departing from the scope of thisdisclosure, that a stiff shaft balloon catheter/sheath may have a sidehole allowing for needle exit from the catheter/sheath. Such an aperturemay be approximately 4 cm from the distal end of the catheter/sheath.The needle may exit the hole either by advancing the needle from a hub(proximal) end all the way out, or the needle may be built into thecatheter/sheath and advanced out into the liver. The end 4 cm willanchor the catheter/sheath and be used for contrast or carbon dioxideportography.

Furthermore, it is anticipated that the disclosure may be used with anintravascular echo type catheter having a built in needle. The echo mayvisualize the portal vein from the hepatic vein. When the portal vein isin sight the needle may be advanced through a window in the catheterdirectly into the portal vein under echo visualization. Theintravascular echo has the advantage of being over a wire allowingproximal hepatic vein puncture and the advantage of direct visualizationof the portal vein and direct visualization of the needle as it tracksthrough the liver parenchyma into the portal vein. Incorporating thisecho technique may allow a simpler method for creating TIPS. This echotechnique may be executed by a kit, where the kit includes anintravascular echo device having a needle window. The intravascular echomay be inserted over the wire through the 10 Fr sheath and the needlecan be advanced under direct visualization anywhere along the hepaticvein without losing access of the hepatic vein. If the intravascularecho device with a side hole for a needle is used there will be theadded benefit of direct visualization of the portal vein while theneedle is advanced.

ICE (intracardiac echo) catheters that are currently available willrequire significant non-obvious modifications that will allow a needleto be advanced through a window that is directed at the portal vein.This can be made by using ICE catheters and creating a side channel.Currently an IVUS catheter (not ICE) which is available as a reentrytool for vascular dissections are in use. The disclosed device will besimilar but specifically designed as an ICE device anchored in thehepatic vein for direct visualized portal venous access.

In conclusion, the disclosed system allows a simpler method ofperforming a TIPS procedure by anchoring a guide device and/or rail thatguides and positions a needle and/or an outer sheath.

Since many modifications, variations, and changes in detail can be madeto the described preferred embodiments of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

1. A rail system for transjugular intrahepatic portosystemic shuntprocedures, the system comprising: a rail line configured for beingpositioned within surrounding tissue and configured to guide thedisplacement of at least one of a needle and an outer sheath.
 2. Therail system of claim 1, wherein the rail line includes a ballooncatheter, and a balloon of the balloon catheter is configured toselectively anchor the rail line to surrounding tissue by the balloonbeing inflated, and unanchor the rail line to surrounding tissue by theballoon being deflated.
 3. The rail system of claim 1, wherein the railline includes a balloon catheter configured for executing wedgevenography by discharging at least one of a gas and contrast through theballoon catheter while a balloon of the balloon catheter is inflated. 4.The rail system of claim 1, wherein the rail line includes a ballooncatheter configured for measuring pressure at a tip of the ballooncatheter while a balloon of the balloon catheter is inflated.
 5. Therail system of claim 1, wherein the rail line includes one or more hooksfor anchoring the rail line to surrounding tissue.
 6. The rail system ofclaim 1, wherein the rail line includes one or more hooks for anchoringthe rail line to surrounding tissue, and the one or more hooks areselectively advanceable and retractable.
 7. The rail system of claim 1,wherein the rail line includes a stiff catheter.
 8. An anchor system fortransjugular intrahepatic portosystemic shunt procedures, the systemcomprising: an inner rail; an outer sheath configured to be advanced andretracted over the inner rail; a needle configured to be advancedbetween the inner rail and the outer sheath; and the inner railincluding an anchor, the anchor configured to anchor the inner rail tosurrounding tissue.
 9. The anchor system of claim 8, wherein the innerrail includes a balloon catheter, and the anchor is a balloon of theballoon catheter, and the balloon is configured to anchor the inner railto the surrounding tissue by being inflated and unanchor the inner railto the surrounding tissue by being deflated.
 10. The anchor system ofclaim 8, wherein the inner rail includes a balloon catheter forexecuting wedge venography by discharging a gas through the ballooncatheter while a balloon of the balloon catheter is inflated.
 11. Theanchor system of claim 8, wherein the inner rail includes a ballooncatheter for measuring pressure at a tip of the balloon catheter while aballoon of the balloon catheter is inflated.
 12. The anchor system ofclaim 8, wherein the anchor includes one or more hooks to hook ontosurrounding tissue.
 13. The anchor system of claim 8, wherein the anchorincludes one or more hooks to hook onto surrounding tissue, the one ormore hooks being selectively advanceable and retractable.
 14. The anchorsystem of claim 8, wherein the anchor includes a balloon and one or morehooks to anchor the inner rail to surrounding tissue.
 15. A method ofperforming a transjugular intrahepatic portosystemic shunt procedure,the method comprising: advancing a rail line into a patient; positioningthe rail line within surrounding tissue; and guiding the displacement ofat least one of a needle and an outer sheath via the rail line.
 16. Themethod of claim 15, wherein the rail line includes a balloon catheter,and a balloon of the balloon catheter is configured to selectivelyanchor the rail line to surrounding tissue by the balloon beinginflated, and unanchor the rail line by the balloon being deflated; andthe method further comprises inflating the balloon to anchor the railline.
 17. The method of claim 15, wherein the rail line includes aballoon catheter configured for executing wedge venography bydischarging a gas through the balloon catheter while a balloon of theballoon catheter is inflated; and the method further comprises executingwedge venography via the balloon catheter.
 18. The method of claim 15,wherein the rail line includes a balloon catheter configured formeasuring pressure at a tip of the balloon catheter while a balloon ofthe balloon catheter is inflated; and the method further comprisesmeasuring pressure at the tip of the balloon catheter while the balloonis inflated.
 19. The method of claim 15, wherein the rail line includesone or more hooks for anchoring the rail line to surrounding tissue; andthe method further comprises anchoring the rail line via the one or morehooks.
 20. The method of claim 15, wherein the rail line includes aballoon and one or more hooks to anchor the rail line to surroundingtissue; and the method further comprises anchoring the rail line via atleast one of the balloon and the one or more hooks.